510(k) · Cleared
ClearedFoothills Surgical Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foothills Industries, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Feb 3, 2005 as substantially equivalent to K031287 (3M Company, 2003) and 1 other predicate after a 269-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Feb 3, 2005
- Review
- 269 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830822 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK830822 Eye DrapeCooperVision, Inc. · 1983
- This deviceK041224 Foothills Surgical DrapesFoothills Industries, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830822 | Eye Drape | CooperVision, Inc. | 1983 | — |
| 0 (this device) | K041224 | Foothills Surgical Drapes | Foothills Industries, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031287 | Steri-Drape Surgical DrapesSummary page 1…s: Foothills Industries surgical drapes and utility drapes are substantially equivalent to surgical drapes and utility drapes currently marketed by 3M Steri Drape (K031287) and Alcon (K830822). Description of Device: Foothills Industries disposable surgical drapes and utility covers are devic… | 2003 |
| * | K830822 | Eye DrapeSummary page 1…ndustries surgical drapes and utility drapes are substantially equivalent to surgical drapes and utility drapes currently marketed by 3M Steri Drape (K031287) and Alcon (K830822). Description of Device: Foothills Industries disposable surgical drapes and utility covers are devices made from natural… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K031287.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041224: Foothills Surgical Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041224
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026